The Monitoring of Protein Stability in Fresh Frozen Plasma over Pre-Determined Intervals of Storage.
University of Wales Institute Cardiff
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Fresh Frozen Plasma (FFP) is presently stored at below -30oc as studies indicate that once frozen, the labile plasma proteins remain stable. However, there is limited data supporting this, and quality monitoring techniques occur prior to freezing. Therefore, the aim of this study is to support this statement by monitoring the concentration of factor VIII, fibrinogen and total protein throughout a period of its storage. A total of 20 units of FFP were pooled in groups of 4 and separated out to give of 5 sets of identical FFP units and were tested for Factor VIII, Fibrinogen and Total protein concentration. These were performed at Day 0 prior to freezing and at 3 months, 6 months and 9 months post thawing. The study indicated statistically significant variations in the concentrations of Fibrinogen and Total Protein. The greatest variation was perceived in the Fibrinogen assay which was not as expected due to the knowledge that Factor VIII is the most labile of the marker proteins. Factor VIII concentration variations were observed as expected, however these were not statistically significant when an ANOVA test was performed. The results however remained in support of the current Guidelines for the Blood Transfusion Services of the United Kingdom with reference to the set quality concentrations. Analysing the results, quality assurance queries may arise due to a selection of the units which already border the criteria set, with the results indicating possible decreases in concentration throughout the storage period. The deviations experienced in this study can’t be used to determine any clinical significance due to a number of contributing factors. The integration of selected pools with uniformed ABO group allowed for a controlled analysis of the selected pools however, there were no variations in these uniformities and therefore the level of effect the particular blood group may have had on the result could not be identified. The study did not consider contributing factors such as age, race or the use of oral contraceptives which may have influenced the results. In conclusion the study has supported the understanding that the levels of labile proteins (FFP marker proteins) remain stable throughout storage, however in order to determine whether the variations observed could become clinically significant over the full storage period, a larger, multi-establishment study would be required.
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